Binary composition for prime-boost release of active ingredients like vaccines

Abstract

Therapeutic compositions in solid dose form that comprise a mixture of first amorphous or non-crystalline microparticles comprising a bioactive agent and second amorphous or non-crystalline microparticles that comprise the same or different bioactive agent. The compositions provide a primary pharmacological response (first microparticles) and a second “boosting” effect (second microparticles) produced by releasing the agent over a linger period.

1 . A therapeutic composition in solid dose form comprising a powder blend of first amorphous or non-crystalline microparticles comprising a bioactive agent and second amorphous or non-crystalline microparticles comprising the same or a different bioactive agent, said first microparticles providing a primary pharmacological response and said second microparticles providing release of the agent contained therein over a longer period.  
     
     
         2 . The composition according to  claim 1 , wherein the or each bioactive agent is an immunogen.  
     
     
         3 . The composition according to  claim 2 , wherein the immunogen is an attenuated bacteria, or an immunogenic peptide/protein obtainable from a bacterium.  
     
     
         4 . The composition according to  claim 2 , wherein the immunogen is a viral particle.  
     
     
         5 . The composition according to  claim 1 , wherein the first bioactive agent and/or the second microparticles comprise an adjuvant.  
     
     
         6 . The composition according to  claim 1 , wherein the bioactive agents are the same.  
     
     
         7 . The composition according to  claim 1 , wherein the second microparticles comprise, as a vehicle, a stabilizing polyol.  
     
     
         8 . The composition according to  claim 1 , wherein the second microparticles comprise a HDC.  
     
     
         9 . The composition according to  claim 1 , wherein the first and second microparticles are from 0.1 μm to 100 μm in diameter.  
     
     
         10 . The composition according to  claim 1 , wherein the first and second microparticles are from 0.5 μm to 3 μm in diameter.  
     
     
         11 . The composition according to  claim 1 , wherein the first microparticles comprise, as a vehicle, a stabilizing polyol or a hydrophobic derivatised carbohydrate (HDC).  
     
     
         12 . The composition according to  claim 11 , wherein the first microparticles comprise a stabilizing polyol.